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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Maquet Orchide - 03700712418281

OHDII FHD QL AIR04 E/U
MAQUET SAS
ARD568803968
Not in Commercial Distribution

  • 03700712418281 ()


  • Surgical video camera

NORDENT MANUFACTURING INC - 00840018628656

BURNISHER, DE, JUMBO BALL#25 E
NORDENT MANUFACTURING INC
REBR25-29
In Commercial Distribution

  • 00840018628656 ()


  • Manual dental burnisher, reusable

NORDENT MANUFACTURING INC - 00840018645462

PERIODON. FIL E ORBAN 10-11, D
NORDENT MANUFACTURING INC
REFPO10-11
In Commercial Distribution

  • 00840018645462 ()


  • Periodontal file/rasp, manual

NORDENT MANUFACTURING INC - 00840018645257

PERIODON. FIL E ORBAN 10-11, D
NORDENT MANUFACTURING INC
CEFPO10-11
In Commercial Distribution

  • 00840018645257 ()


  • Periodontal file/rasp, manual

PFT Kit E, VBMax30E - 00817081022292

Pulmonary Function Testing Kit E, VBMax30E
A-M SYSTEMS, LLC
PFT Kit E, VBMax30E - 189130
In Commercial Distribution

  • 00817081022308 ()
  • 00817081022292 ()
189130

  • Pulmonary function testing kit

PFT Kit E, VBMax28E - 00817081021950

Pulmonary Function Testing Kit E, VBMax28E
A-M SYSTEMS, LLC
PFT Kit E, VBMax28E - 189128
In Commercial Distribution

  • 00817081021967 ()
  • 00817081021950 ()
189128

  • Pulmonary function testing kit

Sklar® - 10649111101335

UNIVERSAL D/E SCALER #15/33
SKLAR CORPORATION
41-640
In Commercial Distribution

  • 10649111101335 ()


  • Manual dental scaler, reusable

Sklar® - 10649111086281

ROUX D/E RETRACTOR MEDIUM 6"
SKLAR CORPORATION
60-1102
In Commercial Distribution

  • 10649111086281 ()


  • Hand-held surgical retractor, reusable

Sklar - 10649111226410

COTTLE ELEV CM-GRAD D/E 9
SKLAR CORPORATION
41-1235
In Commercial Distribution

  • 10649111226410 ()


  • Bone lever/elevator, reusable

Sklar® - 10649111112850

TOWNER SCALER D/E U-15/30
SKLAR CORPORATION
41-709
In Commercial Distribution

  • 10649111112850 ()


  • Manual dental scaler, reusable

Hip Instruments - 07630040746205

Trial hooded PE liner Ø36/E
Medacta International SA
01.32.10.0063
In Commercial Distribution

  • 07630040746205 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Hip Instruments - 07630040746199

Trial hooded PE liner Ø32/E
Medacta International SA
01.32.10.0062
In Commercial Distribution

  • 07630040746199 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Hip Instruments - 07630040746182

Trial hooded PE liner Ø28/E
Medacta International SA
01.32.10.0061
In Commercial Distribution

  • 07630040746182 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Hip Instruments - 07630040746175

Trial hooded PE liner Ø22/E
Medacta International SA
01.32.10.0060
In Commercial Distribution

  • 07630040746175 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Hip Instruments - 07630040745987

Trial flat PE liner Ø36/E
Medacta International SA
01.32.10.0041
In Commercial Distribution

  • 07630040745987 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Hip Instruments - 07630040745970

Trial flat PE liner Ø32/E
Medacta International SA
01.32.10.0040
In Commercial Distribution

  • 07630040745970 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Hip Instruments - 07630040745963

Trial flat PE liner Ø28/E
Medacta International SA
01.32.10.0039
In Commercial Distribution

  • 07630040745963 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Hip Instruments - 07630040745956

Trial flat PE liner Ø22/E
Medacta International SA
01.32.10.0038
In Commercial Distribution

  • 07630040745956 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Hip Instruments - 07630040755917

DM Converter Trial Liner E/DMC
Medacta International SA
01.32.10.0283
In Commercial Distribution

  • 07630040755917 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Hip Instruments - 07630040755702

Trial hooded PE liner Ø36/E
Medacta International SA
01.32.10.0141
In Commercial Distribution

  • 07630040755702 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Hip Instruments - 07630040755696

Trial hooded PE liner Ø32/E
Medacta International SA
01.32.10.0140
In Commercial Distribution

  • 07630040755696 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Hip Instruments - 07630040755689

Trial hooded PE liner Ø28/E
Medacta International SA
01.32.10.0139
In Commercial Distribution

  • 07630040755689 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Hip Instruments - 07630040755672

Trial hooded PE liner Ø22/E
Medacta International SA
01.32.10.0138
In Commercial Distribution

  • 07630040755672 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Darby Dental Supply, LLC - 00889813038451

EXCAVATOR LONG SHANK DE33 D/E
DARBY DENTAL SUPPLY, LLC
9512092
In Commercial Distribution

  • 00889813038451 ()
9512092

  • Dental excavator, reusable

Darby Dental Supply, LLC - 00889813038444

EXCAVATOR LONG SHANK DE32 D/E
DARBY DENTAL SUPPLY, LLC
9512091
In Commercial Distribution

  • 00889813038444 ()
9512091

  • Dental excavator, reusable

Darby Dental Supply, LLC - 00889813038437

EXCAVATOR LONG SHANK DE31 D/E
DARBY DENTAL SUPPLY, LLC
9512090
In Commercial Distribution

  • 00889813038437 ()
9512090

  • Dental excavator, reusable

Drive - 00822383283227

Regulator,D/E,Gr,0-15L 1ea
Drive Devilbiss Healthcare
18302GN
In Commercial Distribution

  • 50822383283222 ()
  • 00822383283227 ()


  • Oxygen therapy conserving regulator

Drive - 00822383568263

CompetBed,HiLo SemiElect, Ful Rail1 e
Drive Devilbiss Healthcare
15570FR
Not in Commercial Distribution

  • 00822383568263 ()


  • Basic electric home bed
  • Electrical assistive bed

Sklar® - 10649111320286

D/E ROACH CARVER PORCELIN/WAX
SKLAR CORPORATION
48-428
In Commercial Distribution

  • 10649111320286 ()


  • Dental wax carver

Sklar® - 10649111318214

FISCHL SHOE HORN RETR D/E
SKLAR CORPORATION
57-1440
In Commercial Distribution

  • 10649111318214 ()


  • Hand-held surgical retractor, reusable

Sklar® - 10649111301247

THOMAS WAX CARVER D/E #5
SKLAR CORPORATION
48-296
In Commercial Distribution

  • 10649111301247 ()


  • Dental wax carver

Sklar® - 10649111300110

WAX CARVER THOMAS #4 D/E
SKLAR CORPORATION
48-288
In Commercial Distribution

  • 10649111300110 ()


  • Dental wax carver

Sklar - 10649111337505

CURETTE EXCA D/E 1-3 1.5X2.5MM
SKLAR CORPORATION
97-0536
In Commercial Distribution

  • 10649111337505 ()


  • General-purpose curette

Sklar - 10649111336768

CURETTE EXCA D/E 1-2 1.5X2MM
SKLAR CORPORATION
97-0532
In Commercial Distribution

  • 10649111336768 ()


  • General-purpose curette

Sklar® - 10649111390357

CENSITRAC READY MEYERDING RETR "E" 7"
SKLAR CORPORATION
22-8214C
In Commercial Distribution

  • 10649111390357 ()


  • Hand-held surgical retractor, reusable

MULTIX SOLUTIONS - G0353044970000

MULTIFUNCTIONAL MULTIX BELLAVISTA 1000 E TROLLEY
MULTIX SOLUTIONS SRL
X3
In Commercial Distribution

  • G0353044970000 ()
304.497.000

  • Electromechanical device/system transport trolley

MULTIX SOLUTIONS SRL - G035000NKV3300

NKV330 X1 TROLLEY + ACCESSORIES - E/X1-330.000
MULTIX SOLUTIONS SRL
X1
In Commercial Distribution

  • G035000NKV3300 ()
000NKV330

  • Electromechanical device/system transport trolley

Sklar® - 10649111178757

VOLKMAN BONE CURR D E 8"
SKLAR CORPORATION
40-7280
In Commercial Distribution

  • 10649111178757 ()


  • Bone curette, reusable

Sklar® - 10649111174322

VOLKMAN BONE CURR D E 5"
SKLAR CORPORATION
40-7250
In Commercial Distribution

  • 10649111174322 ()


  • Bone curette, reusable

Sklar® - 10649111214462

MANNERFELT TENDON HOOK D/E 6"
SKLAR CORPORATION
47-3540
In Commercial Distribution

  • 10649111214462 ()


  • Soft-tissue surgical hook, reusable

Vision 2 - 00817978025405

E. coli O 28 : K 73
PRO-LAB, INCORPORATED
PLA540
In Commercial Distribution

  • 00817978025405 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025375

E. coli (O&K) Polyvalent III
PRO-LAB, INCORPORATED
PLA537
In Commercial Distribution

  • 00817978025375 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025368

E. coli O 128: K 67
PRO-LAB, INCORPORATED
PLA536
In Commercial Distribution

  • 00817978025368 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025351

E. coli O 127: K 63
PRO-LAB, INCORPORATED
PLA535
In Commercial Distribution

  • 00817978025351 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025344

E. coli O 126: K 71
PRO-LAB, INCORPORATED
PLA534
In Commercial Distribution

  • 00817978025344 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025337

E. coli O 125: K 70
PRO-LAB, INCORPORATED
PLA533
In Commercial Distribution

  • 00817978025337 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025320

E. coli O 124: K 72
PRO-LAB, INCORPORATED
PLA532
In Commercial Distribution

  • 00817978025320 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025313

E. coli O 86: K 61
PRO-LAB, INCORPORATED
PLA531
In Commercial Distribution

  • 00817978025313 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025306

E. coli (O&K) Polyvalent II
PRO-LAB, INCORPORATED
PLA530
In Commercial Distribution

  • 00817978025306 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978025290

E. coli O 119: K 169
PRO-LAB, INCORPORATED
PLA529
In Commercial Distribution

  • 00817978025290 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent
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